PMA P070008S071
- Device
- STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD
- Applicant
- Biotronik, Inc.
- PMA number
- P070008
- Supplement
- S071
- Product code
- NKE
- Decision date
- 2016-03-29
- Classification
- Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p)
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Approval order statement
- Changes to visual inspection criteria and incoming inspection sample size for polyurethane tubing.
Current openFDA PMA Record#
- Device
- STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD
- Applicant
- Biotronik, Inc.
- PMA number
- P070008
- Supplement
- S071
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2016-03-29
- Decision code
- OK30
- Date received
- 2016-03-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to visual inspection criteria and incoming inspection sample size for polyurethane tubing.